Federal Court of Appeal defers to Health Canada on interpretation of CSP Regulations

In its first decision addressing and interpreting the scope of the Certificate of Supplementary Protection Regulations, the Federal Court of Appeal found that the Minister's refusal to issue a CSP for a patent covering GSK's SHINGRIX® was reasonable.

The Court of Appeal's decision, Canada (Health) v GlaxoSmithKline Biologicals SA, 2021 FCA 71 was an appeal from the Federal Court decision in 2020 FC 397, where the Federal Court set aside the Minister's decision refusing to issue the CSP.[1]

The Court of Appeal held that the Federal Court erred in concluding that the Minister's interpretation of "medicinal ingredient" under the CSP Regulations was unreasonable, and allowed the appeal. In doing so, the Court of Appeal provided guidance on the definition of "medicinal ingredient" and "a claim for the medicinal ingredient or combination of all the medicinal ingredients" under subsection 3(2) of the CSP Regulations.

The Minister's Decision

GSK applied for a CSP for CA 2,600,905 (the "905 Patent"), which claimed both the antigen and adjuvant in SHINGRIX®, a vaccine useful in the prevention or amelioration of shingles. The Minister refused GSK's application on the basis that the claims at issue were not eligible for a CSP because the claims were not to the medicinal ingredient or use of the approved medicinal ingredient, as required per subsection 3(2) of the CSP Regulations. In refusing to issue the CSP, the Minister took the position that the adjuvant was a non-medicinal ingredient, and the 905 Patent therefore claimed a formulation.

The Minister justified its refusal by relying upon Health Canada's internal Guidance Document classifying adjuvants as excipients, i.e., non-medicinal ingredients. The Minister's refusal relied upon a desired "linguistic consistency" in terms of the treatment of adjuvants within Health Canada.

The Federal Court Decision

GSK applied for judicial review of the Minister's decision, and the Federal Court allowed the application, ordering the matter to be remitted to the Minister for redetermination. In doing so, the Federal Court noted its view that "active ingredient", the term used in Canada-European Union Comprehensive Economic and Trade Agreement (CETA), would include an ingredient such as the adjuvant whose biological activity is necessary for the clinical efficacy of the vaccine.

The Federal Court found that the Minister adopted "administrative tunnel vision" by requiring that a medicinal ingredient have an independent desired effect on the body, i.e. in this case, the antigen specific cellular and immune response. The Federal Court also commented that the Minister's interpretation of "claim for the medicinal ingredient" was hard to justify, for nothing other than the RIAS could support the exclusion of formulation claims nor justify excluding novel and useful vaccines, such as SHINGRIX®.

The Federal Court of Appeal's Decision

After a detailed review of the CSP regulatory scheme, the Federal Court of Appeal, assessed whether the Minister's construction of the expressions "medicinal ingredient" and "claim for the medicinal ingredient" was reasonable, ultimately holding that they were.

FCA's comments on CETA and the sui generis protection agreed to under Article 20.27

The FCA confirmed the relevant objective of CETA was to ["p]rovide adequate and effective protection and enforcement of intellectual property rights in the territory where [CETA] applies", and in particular, that the protection provided by a CSP is "intended to address a portion of the patent term that is spent in research and development and regulatory review towards the approval of a pharmaceutical product that contains a new active ingredient or a new combination of active ingredients."[2]

Continuing, the FCA commented that although "the objective is to grant some "patent-like rights" to compensate for the time lost in obtaining approval of innovative drugs and vaccines, Canada only understood and agreed to a very specific and limited way of doing so".[3]

In that regard, the FCA confirmed that Canada chose to adopt a policy wherein only "innovative drugs or pharmaceutical products that contain a new active or medicinal ingredient or a new combination of active or medicinal ingredients that are eligible", and only those where "the authorization for sale for the pharmaceutical product or drug [is] the first issued in Canada with respect to this new active or medicinal ingredient or new combination of active or medicinal ingredients".[4]

The Minister's interpretation and application of the term "medicinal ingredient" was reasonable

As there is no definition of "medicinal ingredient" in the CSP Regulations, the FCA looked to the interpretation of similar language in the PMNOC Regulations and its case law (which Gauthier JA. noted regularly uses the expression "active ingredient"), as well as the Food and Drug Regulations.[5]

The FCA also considered whether the Minister's interpretation was consistent with CETA - which itself uses altogether different language. Instead of using the expression "medicinal ingredient", the FCA noted that CETA uses the expression "active ingredient or combination of active ingredients of a pharmaceutical product".[6]

After looking to these sources for guidance, the FCA ultimately concluded that parliament must have intended the terms "active ingredient", as it has been regularly used, and "medicinal ingredient" to mean the same thing.[7]

The FCA also found persuasive the reasoning of foreign case law (with apparently very similar facts) on the meaning of "active ingredient" in the definition of "product" from the European Regulation from which the CETA language originates. [57-60] In that regard, the European Court of Justice adopted a definition of "active ingredient" that does not cover a substance that does not have any therapeutic effect on its own[8] – similar to the interpretation put forward by the Minister in the present case.

While the FCA ultimately agreed that the Minister's decision was reasonable, they were also prepared to accept that it was not the only possible reasonable interpretation. Nevertheless, since the applicable standard of review was reasonableness, the Court held that this standard of review does not permit the Court to choose the interpretation it prefers or finds most logical.[9]